The Raleigh News & Observer on Wednesday examined how the expected congressional approval in 2007 of a bill that would renew the FDA Prescription Drug User Fee Act has “pharmaceutical and biotech executives worried” over unrelated provisions that Democrats might attach to the legislation. According to the News & Observer, Democrats, who will take control of Congress in January 2007, might attach to the bill “price controls under Medicare, more safety assessments, provisions that would open the debate on stem cell research and requirements to publish all late-stage drug-testing results.”
Marc Scheineson, an attorney who represents pharmaceutical companies, said that the bill “could become a Christmas tree with lots of ornaments.” Pharmaceutical companies “are turning to lobbyists and consultants” in Washington, D.C., to prevent the attachment of such provisions to the bill, the News & Observer reports. Bruce Bunyan, vice president of global public policy at Talecris Biotherapeutics, said he is most concerned about provisions that could delay the approval of new medications (Vollmer, Raleigh News & Observer, 12/13).
The Mother Jones article Congress vs. Big Pharma: Let the Games Begin offers a differing opinion. James Ridgeway writes:
In the end, Congressional Democrats may not accomplish much to help patients, but they will likely launch the first serious investigations of the industry in decades. (The only pharma oversight effort in the past six years, led by Charles Grassley (R-Iowa) in 2004, focused on poor FDA oversight of drugs such as Vioxx).
Personally, I’m going to cross my fingers and try to stay positive about the possibility of reform. But Big Pharma lobbyists have a whole lot of money in their briefcases; it’s a lot to overcome.18